Why The Ambien Dosage For Women Is Lower

ambien 10mg pill bottleIn 2013, the U.S. Food and Drug Administration announced that the ambien dosage for women would be halved – down to 5mg. But is this unfair for female insomniacs?

Are the protests of insomniacs who rely on Ambien reasonable considering the new evidence for the potential risks of a higher Ambien dosage?

To answer this question, some background to the issue is needed.

The new ambien dosage

This week, the United States Food and Drug Administration (FDA) announced  that the manufacturers of the sleeping pill Ambien, and other sleeping pillls containing Zolpidem, would have to reduce the dosage.

The standard recommended Ambien dosage for women was reduced from 10mg to 5mg. And for extended release formulations, the dosage was reduced from 12.5mg to 6.25mg.

The FDA also decided that for men the dosage would be better if lowered, though isn’t an actual requirement.

In addition to the dosage being lowered, the FDA further adds that medical practitioners should advise patients taking sleeping pills containing Zolpidem that they are at a higher risk of impaired mental alertness.

Clinical trials showing worse driving skills

The reason is that clinical trials and driving simulation studies have apparently shown that women perform some tasks, such as driving, less well the morning after taking Ambien.

They found that women eliminate Zolpidem slower than men, though men also have a small chance of driving worse the next morning.

This was widely reported in the news, but what’s particularly interesting to me is the reaction from many people who rely on such sleeping pills to manage their insomnia.

The comments sections of online news articles show a strong reaction from people who believe that they tolerate their higher Ambien dosage very well. Many people feel they pose no potential threat to others from activities such as driving.

Unsurprisingly, the manufacturers of Ambien, Sanofi, also released a statement saying that they believe Ambien to be safe according to their clinical data and 20 years of use by millions of people.

Ambien has indeed had a great deal of testing by people – it’s the most popular sleeping pill available in many countries. And in 2011 in the United States, 44.8 million prescriptions were written for sleeping pills containing Zolpidem.

With so much apparently safe usage of the higher Ambien dosage and other Zolpidem containing sleeping pills, how bad could the results of these simulation studies have been?

Too much Ambien still in the bloodstream the next morning

woman falling asleep while driving

The FDA reports that recent driving simulation studies found that if people have over 50 ng/mL Zolpidem in the blood, then there’s an increased risk of having a driving accident.

The simulation studies involved 250 men and 250 women taking a dose of 10mg Ambien.

8 hours after dosage, they discovered that 15% of women and 3% of men exceeded the levels of 50 ng/mL, with 4 people having more than 90 ng/mL.

The results of the group taking the extended-release 12.5mg show even higher incidents of elevated Zolpidem amounts in the blood: 33% of women and 25% of men.

Assuming there are many people taking the higher Ambien dosage just before going to bed, as advised to do so, and then driving the next morning, the studies do appear to give cause for concern.

What the manufacturer of Ambien says

This issue isn’t new news, with the following statement appearing on Sanofi’s website:

Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem

They then go on to say:

Due to the risk to the patient and the community, discontinuation of Ambien CR should be strongly considered for patients who report a “sleep-driving” episode.

So should people be given a chance to use the old Ambien dosage, and hope that if they are one of the few people (and admittedly, research does suggest that thankfully sleep-driving is very rare) then they will be responsible to themselves and others and discontinue the drug?

Or should anything that carries such a potentially life threatening risk be seriously addressed?

Well, perhaps the answer can be found in another statement on Sanofi’s website:

As with “sleep-driving”, patients usually do not remember these events.

So if patients don’t always remember that they were sleep-driving, how can they be expected to report the episode and therefore discontinue the drug?

Why insomniacs feel it’s unfair

When reading the many angry comments left on news websites by insomniacs who had the higher Ambien dosage, 5 main points come across:

1. That they feel they shouldn’t be punished because the drug can have dangerous effects on a minority of people.

2. That the dosage should be tailored to each individual’s needs.

3. That they believe some people don’t follow the guidance properly (taking the sleeping pill at the wrong time, or mixing it with alcohol) and this is why dangerous behavior can occur.

4. That if they don’t get a good night’s sleep, they are even more at risk of having a driving accident.

5. Some people don’t drive anyway, so why should they suffer because of those that do?

While it’s understandable that people who feel Ambien has transformed their lives after suffering from insomnia, the risks have to be balanced.

Although the FDA states that only a few dozen incidents of sleep-driving involving Ambien have been reported, they suspect there have been many more unreported cases. And many of these cases could well have been catastrophic in their consequences.

Should the reduction in the dosage of Ambien  have been allowed?

ambien pillsSleeping pills aren’t meant to be a long-term solution, as I discussed in a previous article. If the research in that article is true, and many people have been using sleeping pills like Ambien for an excessively long time, then perhaps the lowering of the dose might have a positive long-term effect, even if it’s difficult for people in the short term.

The FDA’s research does appear to be quite conclusive. Even without misusing the sleeping pills, many people are at a higher risk of an accident after taking the previously recommended Ambien dosage, and therefore the community is also at risk.

In an ideal world, it would of course be better if patients can have a tailored approach. I can completely understand why, for example, that people who don’t drive or operate dangerous machinery would be so annoyed by this.

I also understand that there are so many factors involved in how safely someone drives, that it’s perhaps unfair to group everyone in one pot.

I guess another problem, and perhaps one the FDA themselves won’t want to admit, is that it’s not just the patients that have to act responsibly, but also the doctors. Do they trust all doctors to prescribe carefully, and not give in to patients’ demands for a higher dose even if they think that patient is a higher risk?

And do doctors have the time or resources to carefully evaluate exactly what the ideal dose would be from one person to the next?

Maybe at the end of the day the FDA decided that a blanket ban on higher doses would be the simplest and easiest way to eliminate the risk. Even if that means that some people – especially women – who don’t present a risk, feel that their sleep is going to suffer as a result.

57 CommentsLeave a comment

  • I am 80 years old and have fibromyalgia as well as life long insomnia. If I don’t sleep well my fibromyalgia flares and I am unable to function and in bed. Am on wonderful fibro meds but sleep is critical. I have 10 Ambien which works well to allow me to live a good life. Now the government is telling me I can’t have a med that is crucial to my well being. Tried others but Ambien works the best!

  • Hello to all of my fellow insomniacs and may your higher power be with you always. Its is truly one of the most uncomfortable and debilitating problems that I’ve been forced to live with and it gives me great sorrow to not feel my best at this age (63) . I’m not going to do the laundry list of my problems, but do want you to know why I have insomnia (according the military doctors) and now the civilian equivalents. I suffered some type of brain injury in the military (yes it is documented and I am treated for it) that caused seizures for about three years. It “could” have been a hit to the head and it could have been exposure to depleted uranium while stationed over seas. The seizures started when I was about 35 yrs old, but the insomnia didn’t hit until I was closer to 45. Lots of issues in my family could have created a double or triple whammy to make my brain go haywire. To the present. I am being prescribed 10mgs of zolpidem and this whas at the insistence of my pleas to a decent and concerned psychologist. She told me about the so called laws and also told me she didn’t agree that women should be treated as a “half breed” in need of “half care” (my WOrDS not hers). I weigh about 170 pounds and am pretty thick (size 14-16 to be comfortable. I am bigger than some men etc. I believe medication should be prescribed for a person based on their personal (individual) medical problems and body mass/health. I am VERY conscience of other medications and have even taken myself off of pain meds (every opiate under gods creation) to almost none with extreme consequences (almost seized out). I did it however to stop the feeling that I was in fact gong to seize out. I was taking a muscle relaxer a synthetic opiate ambien and blood pressure pills. This was enough to set my body adrift from my mind. I did what I felt was right by tapering off all drugs except an occasional pain pill, (to include OTC aspirin and Benadryl as needed) my BP and thyroid meds. I feel better but unlike some of you I still don’t sleep more than 4 hours with an occasional 7 hour sleep marathon somehow in between when my body just says so. I have no control over my sleeping patterns, but keep my room dark, quiet and cool. I alspo believe in all natural foods (via fruits and vegetables and protein) and one of these (lemons) has become a godsend for healing. I guess I’m trying to say is that for some of us, not even 10mgs works (much) but any sleep is better than none. The though t of doing with out sends me into panic mode and my BP rises (fast horribly} to the point that I end up either drinking a 12 pack of beer or go to the ER for their usual condescending IV and BS that makes me beg for something to bring my BP down so I don’t die in the friggin presence.

    My help: cool and dark room complete quiet except white noise (Grace and Frankie or the GGs works for me) lots of water or lemon with water, half a Benadryl (if yoru allergies require one) and a few beers. And to all, a GOOD NIGHT

  • I’ve suffered from insomnia for years. Plus, I live in constant pain. I suffer from tumor in my brain stem. Which means severe head pains. I have a spinal fusion with a cage; my back locks in place. I also have RLS. Basically, I’m falling apart.
    Sleep gives me a rest from the pain. I have to have that 10mg, at least. Those 5mg pills don’t even begin to make me drowsy.
    Sure, I keep getting all those same warnings. I’m a woman so I should be on a lower dose. I’m going to have side effects. I’m a stay at home mom who doesn’t drive. I wake up just fine. Without my meds, sleep is nonexistent. Even with the ambien, I also take pain med & muscle relaxer. Sleep like a baby!
    My husband takes 5mg & his sleep isn’t that good. He wakes up tired because he isn’t getting enough sleep.That proves to me that the10mg is far more superior.

  • Although Zolpidem was “not intended for long-term use”, I, like many others, have taken it for years. 15 years, to be exact; 10 mg. Works every night without fail. I wake refreshed after an average 7 hours and never developed a tolerance. I am 73 years old and (gasp!) female. (If you believe everything you read, I should be dead or dying – or at the very least afflicted with Alzheimer’s.) I have tried, unsuccessfully, to wean myself off, but the pills my pharmacy gives me cannot be cut in half nor can they be chipped away. They have a film and they crumble when you try. The ONLY reason I tried to stop taking them was because of all the negative attention the drug began to attract. I saw this coming.
    If Sanofi-Aventis, or another manufacturer of this drug, would come up with either a pill that could be incrementally reduced by 1 mg by me, or 9 mg, 8 mg and so on, I’d feel as though I had a fighting chance. I feel the pain and frustration of every single person who has been denied the medication that helps them sleep. As many have pointed out, physical and mental functionality are very adversely affected when one cannot sleep. I never, ever nap during the day. I turn off the computer and the TV and follow a bedtime routine; pajamas, brush teeth, wash face, take the pill, get my current book and settle down in bed. I’m asleep within 15-20 minutes. I have never, ever gotten up to drive or to eat. I can be wakened. I can be safely on the road within an hour of waking. My driving record is spotless.
    I lead a productive, creative and active life and manage my finances.
    Aside from the mumbo-jumbo blanket edict issued by the FDA, I truly resent being treated as a category and not as an individual. Ultimately, a psychiatrist gave me a prescription for the dose I had been taking (because PCP merely said she would no longer prescribe it ) with refills. My relief at knowing I would continue to be able to sleep and not have to beg my PCP every 30 days for a new script was immense. The psychiatrist said that after taking Zolpidem for so long, I might be able to sleep on my own after many weeks (and what Hell would that entail?)……or I might not. I don’t disagree. But if it is actually harmful to me as an individual, I’d like to see actual laboratory results to prove it and not rely on what happened to someone else. PCPs today would rather prescribe an unnecessary antidepressant than a sleeping pill. That’s because those are drugs that aren’t regulated but are reportedly over-prescribed. Doctors are responding to pressure from the government and health insurers. Gone are the physicians who actually did their best to treat patients as individuals because they are literally being micro-managed. You get 15 minutes or less regardless of what your problem is. We live in an increasingly litigious society, one where no one wants to accept responsibility for their own actions. It’s always somebody else’s fault. Welcome to being nothing more than a customer, as opposed to ‘the patient’, and a check in a categorical box.
    It’s so easy for someone who has never experienced true insomnia to say that ‘natural’ sleep is preferable to a sleeping pill. Of course it is. I couldn’t agree more. But why should those of us who really need something to help us sleep – and know how to follow directions – be deprived of that slumber because of a very small percentage of people who react adversely or abuse medications? Insomnia is a diagnosis. I believe it has an IDC-9 code. Primary Insomnia, not directly associated with any other health problems. I, for one, would love to see statistics regarding the success of people who go to “sleep doctors”. I would like to see data from actual patient interviews, not from the “sleep doctors”.
    Makes me wonder about the agenda of the FDA. They’ve let quite a few bad drugs slip through the cracks because of “studies”, which drug manufacturers skewed in their own favor. Statistics can be so easily manipulated and I question the veracity of same. Case in point: Clinton was supposed to win the election, according to ‘statistics’ and we all know how that turned out. I highly suspect the Zolpidem statistics to be a red herring to cover something far worse. Wait, wait! Maybe it was the Russians. I’ll just bet they hacked into the computers that were compiling all that data.

    • Hi Linna
      Thanks for your comment, and for sharing your thoughts and ideas in both a serious and amusing way. I’m not quite sure how to respond to all that, so I’ll just leave it at thanks!
      Regards
      Ethan

  • I agree with so many of the comments. I have bipolar 2 disorder as well as an anxiety disorder. I have used Zolpidem 10-20 mg for the past 12 years. My mind is constantly thinking and add the racing thoughts on top and I feel I’m going crazy. The 8 hours of sleep I get from taking 10-20 mg of zolpidem has been a blessing. It’s 8 hours of getting my brain to be quiet. Zolpidem 5 mg does nothing for me. I was asked to take a sleep study to see how I was responding to the Zolpidem. The nurse had no trouble waking me up at 5:30 am. I was fully awake and was released to drive myself home, which was a 30 minute trip. The sleep study was “normal” and the doctor stated that it looked like I needed the amount of sleeping medicine I was on. But it doesn’t seem to make any difference. I am positive that had it been abnormal it would have been used against me. I also take Lamictal and Nortriptyline. They both have warning labels of: May cause DROWSINESS and DIZZINESS. Use care when operating a vehicle, vessel or machines. So what is the difference??? I don’t see the FDA sticking their nose in on this. And there are many many more Meds labeled the same. People on opiods don’t have their dosages cut in half. I know they are out driving, more likely impaired. Plus the number of car accidents caused by distracted drivers from text messaging or talking on the phone has increased dramatically. Do I see them having their cell phones taken away from them when driving. I am more afraid of the people driving while on their cell phones. And as stated before, driving while sleep deprived certainly is a cause for concern.

  • i am 65 and my ambien was just cut in half. Now I’m on the 5 mg and sometimes i don’t get to sleep until 6 am and wake up at 7:30am. I have been this for 8 years. I do not work and am terminally ill and need my sleep. This is so dumb. Government gets involved and things get screwed u

  • I am a 79-year-old woman and have been taking 5 mg of Ambien on an average of twice a week for the past ten years. On the nights I don’t take it, I often sleep only two to three hours; on the nights I take it, I sleep five or six hours. I have had no side effects with the Ambien. Restoril makes me dizzy/groggy, and Cognitive Behavioral Therapy has not been effective.

    I am member of Kaiser. Two days ago my doctor called, after I submitted a request for a refill of my Ambien prescription, to tell me that Kaiser no longer prescribes Ambien. I don’t know what to do. I can survive with little sleep when I am here alone, but when family and friends from out of town come to visit, I need to be rested and able to enjoy their company. This is very disturbing.

    • Hi Roberta
      Thanks for your comment. I understand your concern, but unfortunately I can’t advise as I’m not an expert in those health care plans. I think the best thing is to meet with your doctor and discuss alternatives with them.
      Regards
      Ethan

    • Zolpedim is the generic form of ambien.i have been on it for 17 years. There are differences in brands. Teva is cornering the market by all of the prominent pharmacies using only that brand.. Search for a smaller pharmacy who is willing to order Mylan. In my case it was SAMs club. Cheap and effective. Northstar is also better than Teva.. Wallmart Will order it. Wegmans carries it. Best of luck

  • I’m a 68 year-old 170 lb. male who has been taking 10 mg of Ambien for years with no problem. I also have no balance issues and am in better shape than a lot of people younger than me, but my doctor has cut my dosage to 5 mg and now wants me to cut those in half. I asked him what other options there are and he just said “natural sleep is the preferable way to get optimal sleep requirements”. Well thanks, doc. I never would have thought of that. Maybe to get a little sleep I will have to go back to drinking alcohol after being 35 years sober. Alcohol is legal, so it must not cause as much damage on the roads and in dysfunctional families as compared to a drug like Ambien?

    • My response was the same when my doctor reduced strength from 20 mg for 17 years ( female) never drove sleeping or any thing like it. he is tapering me down to zero. I’m so afraid I will have another episode of going 5 days with no sleep or returning to alcohol for relief.

  • I have Peripheral Neuropathy and back problems in my lumbar and cervical area. I am a female and 65 and had to retire due to my pain levels. It has been a struggle to sleep. Recently my pain specialist has reduced my pain meds in half and I am struggling to get even 3 hours of sleep a night. My pain doctor said that if I had cancer, they could prescribe the usual mg. I take 5 mg of Ambien. I used to take 10 mg until my doctor said that he could lose his license for not going along with FDA’s recommendations. I am doing everything I can to eat right and exercise. I just wish that our medical community would get their heads out of their butts and allow patients to take part in making the decisions on their own behalves. It makes me mad that “this too shall change” but its going to take a great deal of effort on all of our parts to inform major companies (pharmaceuticals), newspapers, legislatures and yes maybe even the president to get the powers that be to realize that there are millions of people struggling across the USA and maybe can’t wait until they come to their senses. We are mothers, fathers, and grandparents that suffering and need some ….no a lot of people to step up.

    • Hi Debbie
      Thanks for your comment. I understand your frustration, believe me I do. Having had cancer myself, I appreciate the importance of receiving the treatment you feel you need to get through each day.

      I’m also a big believed in patients having a say in their own treatment – as I’m sure are many medical professionals. That does have to be done within the guidelines allowed though, otherwise there are many patients out there who would no doubt prescribe themselves dangerously large doses of various medications. I’m sure you would be sensible with your choices, but there are probably people out there would feel that 10mg of ambien isn’t enough either, and they need 20, 30 or who knows how much they’d be willing to experiment with.

      I know that’s an extreme situation and the majority of people would choose their treatment carefully. But to do that, they would need to be aware of what the safety guidelines are. And in this case, it’s unfortunate that some people can’t choose to have the dose they know works for them because that dose has a potentially dangerous effect on certain people.

      Regards
      Ethan

    • I took 10mg ambien until the FDA stepped in and said i don’t need that much to sleep. I have driven many times and never fell asleep behind the wheel!! I am pissed off cause now i am lucky to get 5 hours of sleep which does make it dangerous for me to drive!! I now feel tired all the time!! Thanks alot FDA for taking away my nights of sleep!! Lake of sleep affects the body and mental state as well!! I hope you correct this soon so i can sleep again!!

  • If I don’t take ambien I am up all night till 6am and I can go on all that full day to I need to sleep at some point or I will have more health issues. This about driving is nonsense. When I wake up I feel refreshed that I had a solid good nights sleep. Some people have higher tolorance then others where 5 mg don’t work for me it doesn’t even touch me. But 10 puts me to sleep 20 min. After I take it maybe these other people abuse it . They won’t tell you that they may drink with it and is groggy the next morning or some may take even more than 10 mg. Because with me sometimes 10 don’t work so I don’t take it one night then the next night it works maybe if this happened with other people they may double up now that’s scary they would be out of it in the morning. There’s not to many sleeping pills out there and works with some and not for others they shouldn’t be punished. And to find out the root of why you can’t sleep is imposible sometimes it’s stress or getting older,or fear or you don’t even know yourself what the reason is if you knew it you would of taken action on it already I think the people who want it stopped should shut up and stop meddling and mind there own business.

    • I agree 100% I lay awake for hours on the 5mg. I work a full-time job and a part-time job that’s 7 days a week.I workout the times a week and still can’t fall asleep. I get migraines often from lack of sleep. I work second shift and a full third shift before I can lay down. It’s so aggravating.

  • I am unable to sleep more than 4 hours a night. This is without napping in the daytime. I am a woman. I am an insomniac. What I am not and never have been is a driver! I dont work due to medical problems so I do not lift anything heavy. Why am I being deprived of sleep and only being prescribed 5 mg. ( which does nothing ) compared to the 10 mg I had previously been taken?

    • Hi Carol
      Thanks for your comment. I completely understand your point of view. In an ideal world the guidance would allow for people’s specific circumstances rather than a one-size-fits-all rule.
      Regards
      Ethan

  • I just want to ask the FDA if driving tired is less dangerous than driving after sleeping on Ambien 10 mg. I have heard that driving sleep deprived is as dangerous as driving under the influence of Alchol. I know this to be w fact because a friend from high school was driving exhausted on the freeway and crashed into a try hard median as she was falling asleep at the wheel. She died at age 19, never having drank any alcohol. She just needed good sleep. How can we fight the FDA? I took Ambien since 2009 and have had no side effects except from the AnbienCR. Please let me know what I can do, as no other sleep medicine works for me. I have also tried all the natural sleep aids, and over the counter AIDS. Thank for your help.

    • Hi again Megan
      I responded to your comment left in response to a previous reader with my suggestion for you. But in terms of fighting the FDA, I’m afraid you’re not likely to have much luck with that!
      I’m sorry to hear about your friend – that’s terrible. You do raise a very good question though, and other readers have also said the same. I guess they believe that a lower dose of ambien and the tiredness, but with some sleep, is better than the higher dose of ambien being in the system. And perhaps they feel that for the majority of people, the lower dose is sufficient. For the small number of cases who really can’t sleep at all with the lower dose, perhaps the intention is that they work with their doctor to find something which actually does help.
      Regards
      Ethan

  • I am one of those women who are angry at not being able to have an effective dose of Ambien prescribed. all my life I have struggled with insomnia and delayed sleep onset phase disorder – and I am 69. I was diagnosed with sleep apnea in 1997 and underwent a uvuloplasty – yes, I had my uvula removed! – with the assurance that that would cure it. of course, it did not. then I was prescribed a CPAP, but am completely unable to keep one on all night because they are not designed for the “non-average” head shape – I have a small, round head, and no amount of adjustment *ever* worked. 5 years ago I was prescribed Ambien, and after 5 mg did literally nothing for me, it was increased to 10 mg. That was a miracle. I was able to go to sleep immediately, wake up refreshed without even depending on an alarm, and was productive and energetic throughout the day. I am retired, but my husband is not, and with 10 mg Ambien I was able to spend time with him both at home and when traveling – in short, the quality of my life increased to what the *normal* person experiences daily! one year ago, my new PCP refused to let me continue on that dosage, so reduced me to 5 mg. since then, he has tried me on various combinations of that level of Ambien with other meds and supplements, insisted I’m doing something to prevent myself from sleeping, and my life has been hell. last week I saw another sleep specialist and she has taken me completely off Ambien at any dosage, has me on “pharmacological grade” melatonin 3 mg and has had me purchase a huge bright “wake up” lamp. I am to slowing and gradually change my “sleep habits” to a normal one by adjusting my circadian rhythms in a “normal and natural way.” the results have been nothing short of a big fat nothing. regardless of what time I take the melatonin and bed down, I lie awake, tossing and turning, for 3-4 hours. come morning, I’m so exhausted that I sleep through the strongest light and the loudest alarm, and end up sleeping 10-12 hours. this is torture, pure and simple, and is not that much different from how my entire life was led before the 10 mg Ambien. I won’t even get to see her to report on the “results” for 3 months, and I’m actually terrified at what my mental state will be by then. I feel that I have been abused by the medical profession for this disorder, starting with the advice in my youth to just “go to bed earlier,” through the unnecessary and useless surgery, and now the dismissive attitude that, even though as many as 85% of women have NO side effects at that 10 mg dosage, *I* don’t know my own body and am likely to be one of the 15% – even though I do not, am not, will not be. to me, this is symptomatic of the utter disregard and patronizing attitudes women get from the medical establishment, and I am completely sick of it.

    • Hi Judy
      Thanks for your comment, and I can understand your anger. Sleep is a precious thing, and when it feels like it’s taken away from us by things beyond our control, the natural reaction is frustration through exhaustion.
      Hard as it is, I’m a big believer in natural technique to deal with insomnia, so would agree with what the sleep specialist is suggesting. With the lack of other options right now, I think maybe the thing is to give it your best shot. Try to stay calm about the situation, which although easier said than done – I know – is perhaps your best option. If you go to bed every night believing you won’t sleep without the ambien, you’re creating a self-fulfilling prophecy. You have nothing to lose by trying the advice for a while. If you do feel that your mental state is suffering before the 3 months is up, you can always speak to your doctor or ask to see the sleep specialist and tell them it’s really not working for you.
      So although I hear your pain, I do recommend giving it a little time to see if their advice can work for you. Maybe it will, maybe it won’t. But you won’t know unless you give it your best shot.
      All the best
      Ethan

      • Judy, I have had a very similar life pattern to what you describe. Ambien was an unbelievable gift, especially with school age kids. Other people take it for granted that waking up early is easy and going to bed early is possible. They have no clue! Good luck.

    • SomeoneI know uses medicinal marijuana mabe that would helpI have been taking 10 Mg my Dr know wants to give me 5 mg I already take 15 mg of melatonin and 500 mg of gaba I’m petrified!!

  • The 5 mg does nothing for me. I take Oct sleep aid then the ambien and can get a good sleep like I did with the 10 mg.

    My friend went to a psychologist was was prescribed 20mg! How is that possible? It should be tailored according to individual. I work from home and don’t head out until late afternoon if I have errands to run.

    • Hi there
      Thanks for your comment. I do agree that sleeping pills are best tailored to the individual, but 20mg seems like quite a lot. Perhaps that was before the new regulations came out? And have you checked with your doctor that the mix of sleeping pills you’re using is safe to use? It might be a good idea, just to be on the safe side.
      Regards
      Ethan

  • the FDA is full of sh-t, men are more likely to fall asleep at the wheel then women. Women have struggled with keeping down a job while taking care of new born babies all night and have managed just fine Men on the other hand can get a full night’s sleep and still struggle with waking up in the morning. The FDA pencil pushers are making it even harder for women who need a good night’s sleep and how is being awake all night supposed to make them more alert behind the wheel? What a bunch of Losers

  • I have severe insomnia. After lifelong suffering, in my 50s, I had a sleep study and this was confirmed, along with restless leg syndrome. I also have a neurological muscle disease, it is progressive and crippling, called Charbot Mare Tooth, i was born with it. 5mg zolpidem did nothing for me. I use a walker, wheelchair because I have neuropathy in my legs, arms. I only drive for pleasure, like to go to Walmart.
    Without 10mg zolpidem I usually can manage to go to sleep by 2 or 4am and sleep 3-4 hours until the exhaustion becomes so severe, usually takes a week, then I can sleep 7-8 for a night.
    I just can’t shut my brain off. Zolpidem was a last resort for me after trying anti-depressants which left me long a zombie all day 10mg amytriptiline for example. I have pain all the time in my feet, hops, back and arms.
    My new doctor (we moved) dropped my dose and told me she doesn’t care if I don’t sleep, she doesn’t care about my fatigue or restless leg syndrome. She said she will never under any circumstances give any woman 10mg, ever. So after finally feeling rested, not so cranky, not so foggy headed I get to go back to not sleeping. I feel unseen and this isn’t the first time doctors have done this.
    They are way more healthy than me, get a pretty fair chance for a good quality of life. Not sleeping is not a good quality of life. My later supposedly nice years of aging are not nice. While the answers you give to comments sound sympathetic, they are not helpful to those who truly suffer with insomnia.
    I am praying another doctor will see me, help me, even if it means changing my sleep meds.

    • Hi Tracie

      Thanks for your comment, and I’m sorry to hear you’ve had to, and continue to, deal with such a range of health conditions. You’re right in that I try to be sympathetic, but can’t do a lot to actually help people here in these comments. I’m unfortunately not in any position to change anything about the way the guidelines have been set. So all I can do is offer a space for readers to express their views and considering the fact that things aren’t likely to change where ambien is prescribed, recommend that people do try other alternatives.
      If you’re not happy with your doctor’s attitude towards you, then I would always recommend getting a second opinion. Even if you find the same answer, at least you’ll know that it’s not personal. And perhaps you’ll find some useful advice along the way. I won’t patronize you by offering the same advice I have done to other readers regarding other option for dealing with insomnia as it sounds like you’ve read enough of the comments to know what I’d say. But I do hope you have a think about other things you can do to help improve your sleep.
      All the best
      Ethan

      • Try researching some holistic approach that can be safely added to your current medicine that might give your ambien a boost or relax you naturally before taking ambien. There’s lots of information out there but as a beginner I would suggest that you go see a reputable holistic health professional and share with her or him your ailments and concerns as well as take all of your medication from your other Dr that way she can give you the best possible advice in her field then take her recommendations to your regular Dr and make sure that the holistic herbs and supplements will not interfere with your medication and see what your Dr might think about the combination. We still have old school doctors out there but I’m seeing more and more doctors giving new holistic approach and Dr combination approach a try. Good luck on your journey

    • I too have severe full body pain all the time due to Lupus, RA, Fibromyalgia, Raynaud’s, Emphysema, Neuropathy, Spinal injury, Lyme Disease, and others. I am unable to sleep because of it all. I used to get a decent nights sleep on 12.5 dosage and was enough to be sufficiently rested that I could function next day. Then my dosage was lowered to 6.25. Now I sleep about 3-4 hours at the most, I am fully awake the rest of the night needing to quietly walk all over the house because of the body pain without waking anyone else up that need to work in the mornings. I am disabled & retired and do not need to drive in mornings. I only drive to grocery or dr. appts. in late afternoons. I am miserable all night feeling so tired and sleepy unable to fall asleep, and most of the next day due to the lack of sleep and as a result mostly unable to function and desperately struggling to accomplish simple household tasks. This did not happen on the 12.5 dose. I have told my doctor all of this and he is aware that I am mostly homebound and he refuses to go back to the 12.5 dose. This situation for me is much more dangerous. So, out of desperation I have decided that my best recourse is to purchase some of the OTC P.M. products to take along with my 6.25 ambien and see if that might help. I will start with 1 tablet and add to it until I achieve the needed results. If that does not work then I will take 2 of the 6.25 ambien tablets which will then be the 12.5 dose every 2-3 days or so and see if I can work it out that way somehow. I realize that I will run out sooner and possibly have to spend a few days in misery or maybe since I will gotten some rest beforehand those “out” days will be tolerable with some OTC P.M’s until I can refill. I think it’s total “BS” that sleep aids are supposed to be temporary. Many people struggle with sleeplessness their entire lives and many commit suicide over the desperation created by this condition. My constant pain is what wakes me up and keeps me awake. They tell me they are doing all they can do for my types of pain and that I have to just live with it as is. I don’t think these doctors realize the quality of life they are damning a person to live. I am of the belief that todays doctors are all about money. Money from the drug companies that they get, money from insurers and wherever else they get their kickbacks from. They do not have that caring deep commitment to a patient they used to have. They got into the field for the money, especially the primaries that can barely diagnose and seem to prefer to see well patients mostly.

    • I too have suffered insomnia my whole life. At 55 with having gone through menopause earlier in the year, I feel that my lack of hormones is robbing me of any sleep. For two years I have been taking ten mg of Ambien and only sleeping for about 3.5-4 hours a night. I then tried breaking it in have to see if I could fall asleep on 5. I did, but woke up exactly 4 hour every morning and could not go back to sleep. After several weeks I was so tired, achy, and forgetful. It was not a good quality of life. I could badly function and had no energy. My depression increased. I decided to take my first pill at 10:00 of 5 mg and then save the second half to take at 2 in the morning to try to get a few more hours of sleep. It worked. First I was getting between 6-7 hours of sleep and feeling more energy and awareness. I thought I could have a better quality of life this way. So I did that for two years. Now my primary dr says she can only give me 5 mg due bro new FDA guidelines. I sought out a sleep neurologist to see why I can’t sleep at night, maybe I had a chemical deficiency in my brain preventing sleep. This dr was so not helpful. He put me on sleep deprivation. This was torture for me. I felt tired, grumpy, and depressed for 2 months with zero energy. I need the 19 mg to feel like my body and mind even have a chance of healing and feeling better. The dr said I am just a person who only needs 6.5 hours a night instead of 7-8. If there is another way to feel rested at night, I would understand. But nothing else has worked for me and I never ever sleep during the day. I think my dr should make an exception for me as I have literally tried every know treatment and medication to help me sleep. Even acupuncture didn’t work and cost a lot of money. What can I do now?

      • Hi Megan
        Thanks for your comment. Sorry to hear you’ve had such a terrible time sleeping and are feeling bad because of this. It’s a really tricky one, because the doctors are legally bound to follow those guidelines, and would be very hesitant to make exceptions. So that leaves you to try and cope the best you can. Have you thought about taking a short nap during the day time? As I wrote about in a recent article, having two sleeps instead of one can be very beneficial for many people. If you have the time to do so, it might help your overall energy levels. And even if you don’t sleep, just having a resting siesta can help the body and mind recharge and heal.
        Regards
        Ethan

    • Tracie,
      I have had severe insomnia for many years. Sometimes going two or three nights in a row without sleep. I have had some different issues with ambien. I was very allergic to it unfortunately. My doctor prescribed trazadone. It has been a miracle for me! I take it an hour or so before I go to bed, fall asleep quickly, sleep all night and wake rested. No restrictions, very few side effects. It has given me a new lease on life!

  • Some of us just don’t sleep. And the only thing worse than not sleeping is not sleeping after taking Ambien. Plus I work from home. Now I can’t get the dosage I need and some days I am so exhausted I end up not being able to do anything all day.

    Sanofi ****ed up on Ambien CR by making the 12.5 (supposed to be the equivalent of 10 regular Ambien) 5 initial release and 7.5 on the controlled, which isn’t enough to get to sleep on for a lot of us, but is enough to leave us hungover. They could solve the problem by making the CR 7.5 initial + 5 controlled release.

    Now I’m at the point where 10 only lets me sleep 2 hours and the 12.5 doesn’t let me fall asleep in the first place. So for years I’ve been taking a 12.5 CR + 5 mg regular Ambien. And now I’m supposed to cut back to 5 regular or 6.25 controlled release? Tell me that isn’t more dangerous than taking a higher dosage and staying home or not sleeping at all. When we start combining drugs because we can’t sleep, will the FDA finally listen?

  • I have found a solution to my sleep problem since I can only get 5mg Ambien. I take one ambien, one trazadone, and 2 Advil PM every night! Now I can sleep for at least 6 to 7 hours and wake up totally refreshed!!

    • I take zzz quick 10 mg ambien and 2 xanax 1mg each and I get about 4 hour’s of sleep. I guess that is the best I’m going to get

  • My doctor has prescribed me 10mg and now a (new) pharmacy is telling me they have to verify it because I’m female, whereas my old pharmacy had no problem with the 10mg dosage. 10mg of Ambien barely does anything, most nights I’m still awake and when it does help me to sleep, I get about 4 hours and then wake up. This should be between doctor and patient, as should *all* medications. I am livid at the way healthcare is dealt with in the USA, it’s been taken out of the hands of medical professionals and is dictated by politicians. Studies such as this/these do not take into account everyone, as they’re usually a fairly small sample size and aren’t reproduced enough times to take into account variables… and yet now we have to jump through even more hoops because of a stupid “War on Drugs” that only hurts the people who actually need these medications. After all, if someone is breaking the law to get drugs now, it’s not like making a harsher law is going to get them to stop.

    • Hi Lynn,

      Thank you for your comment, and I can understand your anger and frustration. Like many people, if you feel that a certain dose doesn’t work, then it’s natural to be upset if you aren’t given a dose which you know does work for you.
      At the end of the day though, if you can find a way to beat your sleep problems without using sleep aids, then that’s the best end result. Perhaps if you feel that way about the industry and its politics, it might be time to see if you can beat it altogether and take yourself out of the loop!
      All the best
      Ethan

  • Point is not whether I need 10mg or 5mg. Point is that this decision is patient’s alone. My doctor is supposed to make an educated decision but he works for large clinic and they tell them to follow FDA guidelines . 5mg is about half of what I need . But, thank you big daddies of FDA and medical establishment to help my cute little brain to decide!

    • Hi Kitty

      Thanks for your comment. I can understand your frustration if you’ve been used to the higher dose and the lower dose doesn’t feel as effective. Hopefully you’ll adapt to it though and still find it helps you to sleep.
      Regards
      Ethan

  • Hi my Dr. Prescribed me 15mg of ambien for disruptive sleep apnea and I have heard that for females it is supposed to be 5-10mg? Did he make a mistake or is it OK to take that much in some cases?

    • Hi Breanna

      I’m not sure whether it’s a mistake in them not knowing the recommended maximum daily dose is 5-10 mg, or if they think for some reason you need more and are happy to give you more. Perhaps check with them what they think and take an article with you which explains the dosing recommendation. E.g. you could ask them to check on drugs.com which explicitly states the dosage.
      Regards
      Ethan

  • What were the range of heights/weights of the women in the survey, what was the average height/weight?

    I’m on the tall side for a woman and heavy. 10 mgs worked fine for me, I slept most of the night. I’m lucky if I get 4-5 hours on the halved dosage. Lack of sleep worsens the anxiety I experience and the increased anxiety makes it hard to sleep. I do things like try to keep a sleep routine, use an eye mask to filter out excess light and listen to relaxing environmental sounds (beach, rain). I have also tried melatonin before seeking medication help.

    I’m going through an intensely stressful period of my life right now and I wanted to go back to the 10mg so I could get good sleep a few nights of the week. My dr. suggested switching to Neurontin, at first adding it, then substituting it. I figured I’d give it a shot and if it didn’t work, then go back to the 10 mg. I had a bad reaction to the Neurontin I experienced intense sadness to the point where I questioned if life were worth living, felt like I was coming down with a cold or flu for a week and the congestion triggered an asthma flare up, edema and a rash. All of which either stopped completely or vastly improved when I stopped taking the Neurontin.

    You know the saying if it isn’t broken, don’t fix it? This is a classic case. I’ve also had a bad experience with a Paxil for anxiety, another drug touted as non-addictive (prescribed by a different doctor, about a decade ago). I’m really beginning to doubt the medical field and lose trust as a result of these 2 experiences.

    I’m not saying other alternatives shouldn’t be tried first or that doctors shouldn’t be careful in prescribing Ambien. But do realize some of the “non-addictive” medications can be far worse for your patients. Just because it has a reputation as non-addictive doesn’t mean it won’t cause harm.

    • Hi there

      Thank you for sharing your experiences, and I’m sorry to hear you’ve had such a torrid time with pharmaceuticals. I understand the frustration at not being able to find something which really works for you, and isn’t changed either.

      To answer your question, this quote from the FDA website might help:

      Q6. Do any other factors, such as a patient’s age, weight or ethnicity, have an effect on zolpidem levels?

      A. Based on data from pharmacokinetic trials, no relationship was evident between the zolpidem blood level and patients’ body weight or ethnicity.

      You can find lots more useful information about this on this FDA page when they announced the change.

      You are absolutely right about medications which are non-addictive still causing harm. All medication has the potential to cause some people problems, even over the counter sleeping pills which can be easily obtained. This is unfortunately part of the nature of the pharmaceutical industry.

      I do hope you manage to get through this difficult period of your life, and that you find the help you need and want.

      Best wishes
      Ethan

  • I have taken zolpedim for six years with no side effects! I could take a 10mg Zolpedim and a Trazadone an hour before bedtime, know that I would sleep well, and wake up refreshed and ready to go. I work crazy hours and cannot establish a regular sleep pattern. Some days I have to awaken at 3:30 am to go to work at 5 am and the next day I might go to work at 2pm and work until 10:30 pm. Therefore, I don’t get home one night until two hours after I should have been asleep for the early days! In the past week, the Dr. has prescribed 25mg of Nortriptyline (which did nothing). I slept a total of about three hours all night. Then, he said take 50mg and I was more wired than before and didn’t sleep at all! Then, he gave me Temazepam 15mg which did help me go to sleep, but only allowed about 4 hours sleep and awoke with a raging headache and bad dreams. Today, he recommends take 30mg of Temazepam! I don’t know why they couldn’t leave it alone! If it ain’t broke, don’t fix it!! I’m certain I would be much better off with my Zolpedim and drinking a bottle of wine and driving!

    Sleepless in Kentucky

    • Hiyah Roselyn

      Thanks for taking the time to leave this comment and personal story. I do understand your despair about this, if despair is the right word. If you had something that worked before, and now nothing else does the trick, it makes sense that you would feel frustrated.

      And your comment is very similar to the many more I read on various articles on the internet when this story first broke. The BBC article for example was full of people saying the dose worked wonders for them, so why should they lose out?

      I guess if there was an alternative that worked, it wouldn’t be so bad for people like yourself. But the cocktail of different drugs you’ve been prescribed over the last week doesn’t sound great, and the accumulative effect won’t be doing you much good I imagine. Especially with such a crazy sounding sleep pattern.

      Is there no way you can negotiate different hours at work? And does the new lower dose not work for you at all? I would like to know whether it had any sedative effects, or whether it just flat out didn’t do anything for you.

  • Hello,

    As someone who’s been splitting 10 mg Ambien tablets in half for years (I take them occasionally, as needed) I can’t say I was alarmed when the FDA reduced the recommended dose to 5 mg for women. It is only a recommendation; doctors are still free to prescribe the dose that is appropriate for each patient, depending on his/her needs.

    What I do find alarming, though, are media personalities like Dr. Oz who use such recommendations and the data they are based on (the 10 mg dose left 15 percent of female users groggy and prone to driving accidents) to demonize sleeping pills overall.

    One driving incident caused by a sleeping pill is one too many. Yet the number of driving incidents caused by sleeping pills is tiny compared to driving incidents related to alcohol, which helps put the problem in perspective.

    Non-chemical ways of managing insomnia are preferable to using drugs. But when behavioral remedies don’t work, sleeping pills–prescribed and used judiciously–can be a godsend for people with intransigent sleep problems.

    Media personalities who use information such as this recommendation by the FDA to whip up hysteria are doing nothing to promote the kind of rational discussion about sleeping pills that we really need.

    • Hi Lois

      Thanks for taking the time to leave such a detailed comment. Whilst I am also not personally a fan of sleeping pills, I do respect the fact that many people find them beneficial, and as you say – if used judiciously they can be a Godsend for some people. You are also right about Media personalities not helping the debate if they are blanket demonizing them, but then we should know to take media folk with a pinch of salt anyway…
      I’m not sure how helpful it is to compare sleeping pill related accidents to alcohol related since in most countries drink driving is a serious offense, and the comparison doesn’t mean much to me. I think the risks of driving under the influence of any substance should be judged on its own merits rather than in comparison to other substances. Though one thing to bear in mind is that many people underestimate how safe it is to drive the morning after a heavy drinking session in the same way that some people perhaps think the effects of pills like Ambien should have dissipated after a night’s sleep.

      Thanks again
      Ethan

  • Hi Rocio,

    Thanks for you comments. I believe it is not an all or nothing drug, and that a lower dose will still have a relative effect. I know for example that the standard dose for elderly people is 5mg instead of 10mg, and this even lower dose still works. Doctors also ensure that they lower the dose slowly when people are coming off Ambien if they have been using it for more than a few weeks.
    I imagine that for some people, the lowered dose according to the new regulations may not be strong enough, but for others it may be perfectly adequate and that the original higher dose was knocking them out more than was necessary. So some people will probably feel the reduction in dosage affects their quality of sleep more than others. But the lowered dose will definitely still have a sedative effect – the question is just if it is enough of an effect to make the individual sleep. Then it will up to the individual to be sensible and not mix it with other substances to make up the shortfall, but to give time to the lower dose to have an effect that satisfies them, or talk to their doctor about their unhappiness with the new dosage.
    Regards
    Ethan

  • Great article! Now I’m wondering about what are the effects of reducing the doses of Zolpidem in our system. Is it an all or nothing mechanism, so if you take a lower dose the medicament wouldn’t allow you to make you sleep at all?, or would it make you wake up earlier, for example?… I would like to know more about what will happen with this, because I can imagine a lots of people being desperate enough to explore combined solutions between using this pills and other exotic methods to go to sleep…

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